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To study the efficacy of injection Hyaluronidase given inside spinal fluid as an additional treatment to standard antitubercular therapy in cases of Tuberculous Arachnoiditis.

Intrathecal Hyaluronidase as an add on treatment in cases of Tuberculous Arachnoiditis- an Open Label Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/081414
Enrollment
42
Registered
2025-02-27
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A170- Tuberculous meningitis

Interventions

Intervention1: Intrathecal Injection Hyaluronidase: Under all aseptic conditions, Lumbar Puncture will be done at L3-L4 or L4-L5 level by using 22G spinal needle. Confirmation of Lumbar Puncture will

Sponsors

AIIMS Bhubaneswar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. New cases of tuberculous meningitis diagnosed using clinical, CSF and radiological finding having focal weakness, atrophy, diminished or absent deep tendon reflexes, vision impairment or imaging evidence of basal exudate or optochiasmatic arachnoiditis or spinal arachnoiditis. 2. Within one month of starting antitubercular treatment. 3. Age 18 year or older of both genders.

Exclusion criteria

Exclusion criteria: 1. Confirmed meningitis other than Tuberculosis. 2. Pregnancy 3. Premorbid (prior to the onset of present illness ) mRS 4 or more 4. Patients with gross spinal deformity where Lumbar Puncture is technically difficult. 5. History of severe hypersensitivity reaction to drugs 6. Patients with terminal illness/palliation whose life expectancy is 6 months or less.

Design outcomes

Primary

MeasureTime frame
Improvement in disability measured by Barthel Index score improvement of at least 2 points (at 3 month)Timepoint: 3 months

Secondary

MeasureTime frame
1.Radiological resolution of arachnoiditis and non-development of other CNS complications (evaluated by follow up MRI scan of brain and spine) at 3months. 2.Reduction in Lindegaard ratio at 3 months as measured by TCD 3.Drug related adverse effects. Timepoint: 3 months

Countries

India

Contacts

Public ContactDr Tathagata Ghosh

AIIMS Bhubaneswar

tathagata.20594@gmail.com8670700451

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026